Package for ampoules containing lyophilized products

ABSTRACT

A package for ampuls containing lyophilized products comprising a box adaptable to contain a plurality of the ampuls and formed of at least two assemblable elements, two of which each have an internal orifice for engaging an end of the ampul over a certain length thereof so as to allow breaking of the ampul by grasping one element in each hand.

D United States Patent [151 3,649,437 Galy Feb. 8, 1972 [54] PACKAGE FOR AMPOULES [56] References Cited CONTAINING LYOPHILIIZED PRODUCTS UNITED STATES PATENTS 72 Inventor: Michel caly, Lyon, France 2,638,022 5/1953 Reyes ..225/96.5 UX I 2,659,253 11/1953 Myrick ..8l/3 R [731 Assgnw Amnym mm Mme, 2,700,972 2/1955 Haden ..s|/3 R x Lyon, France [22] Filed: Dec. 29, 1969 Primary Examiner-Frank T. Yost [211 App! N o 888 370 Attorney-Cushman, Darby & Cushman [30] Foreign Application Priority Data [57] ABSTRACT Dec. 27 1968 France 180929 A Package for ampuls Containing lyoPhilized Products prising a box adaptable to contain a plurality of the ampuls 52 US. Cl ..225/96.5, 81/3 R, 206/65 A, and formed of at least two assemblable elements, two of which 225/ 103 each have an internal orifice for engaging an end of the ampul [51] Int. Cl. B261 3/00 over a certain length thereof so as to allow breaking of the [58] Field of Search ..225/93, 103, 96.5; 81/3 R; ampul by grasping one element in each hand.

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ATTORNEYS PACKAGE FOR AMIPOULES CONTAINING LYOJPHILIZED PRODUCTS The present invention relates to a new ampul intended primarily to contain lyophilized products, which has the advantage of being readily broken, and from which the plug of lyophilized product can be extracted without difficulty.

The present invention likewise relates to an apparatus for the manufacture of these new ampuls.

It happens in certain instances that the lyophilization is effected starting from a relatively large volume of suspension in a liquid, which means that this suspension is placed in an open ampul with a relatively large diameter.

Since moreover it is not possible with known devices to proceed to the breaking of a large diameter ampul part, it has been necessary in this case to use ampuls which have a neck at the level of which the break is made, either by a sawed line, or by prestressing of the glass at the time of manufacture of the ampul.

Such ampuls presently in use do not give entire satisfaction because the lyophilized product in the form of a plug of the same diameter as the ampul cannot be extracted through the ampul neck, which makes it necessary to dissolve it inside the ampul.

There is some inconvenience for the user as the result of this, and the objective of the present invention is the development of ampuls for lyophilized products that do not present the above-mentioned drawback.

The present invention relates to a new industrial product which is an ampul intended especially to contain lyophilized products, characterized in that it comprises a cylindrical glass receptacle closed at its ends, the said receptacle presenting, preferably in its midportion, a weakened zone constituted for example by a groove at its periphery, the said zone being preferably covered by a pasted sheet.

The said ampul before filling is a cylindrical receptacle closed at one end and open at the other, in which receptacle there is placed the quantity of solution or suspension that is to be lyophilized. Receptacles thus filled are suitably subjected to lyophilization in a customary manner, to form within them a plug of the lyophilized product constituted by a rather compact mass with a diameter slightly less than the internal diameter of the receptacle and a length that is a function of the quantity of the product. The open end of the receptacle is then closed in a customary manner.

At this stage there is a cylindrical glass tube closed at both ends, containing the plug of lyophilized product.

According to a preferred method of the invention, there is developed, preferably near the middle of the receptacle, a weakened zone obtained by hollowing a groove on the periphery of the tubular body of the receptacle. This can be done by any means, especially by use of a new apparatus that is to be described below.

In this condition, it is possible to store the receptacle containing the lyophilized product, and the peripheral groove has no deleterious effect on the preservation of the product.

To extract the plug of lyophilized product, it is sufficient to take an end of the receptacle in each hand, placing the thumbs near the groove and exerting force that tends to bend the receptacle to cause a clean break of the latter at the level of the groove, the plug of lyophilized product then slipping very readily from the part of the receptacle where it is located.

In an improved modification of the invention, the tubular body of the receptacle is surrounded at the level of the groove by a pasted sheet that tears at the same time as the ampul and which is intended, because of its adhesive part, to hold any small glass splinters that might be produced when the glass is broken.

In a preferred embodiment of the invention the adhesive sheet comprises a self-sticking label that effects the function mentioned above while allowing ready identification of the product that is contained in the ampul.

The present invention likewise relates to a new industrial product that comprises a package that facilitates the opening of the above-described ampuls, the said package being essentially characterized in that it is constituted of two discrete pieces of size sufficient to be grasped separately between the fingers of one hand, and which each present an orifice inside of which it is possible to engage an end of the ampul of the ii I vention.

By virtue of this package, the separate parts of which are placed on the ends of the ampul of the invention, the opening of the said ampul is greatly facilitated because the parts in question allow an amplification of the force exerted by the user.

In accordance with the invention, it is preferable to make the two parts of the package in question of a relatively flexible material such for example as plastic or wood, because the elasticity of the device promotes a good break in the ampul of the invention.

In a preferred embodiment of the device described above, the two parts or elements of the package constitute the cover of a box that contains the ampuls of the invention. The user thus has at his disposal a simple and practical means for storing and opening the ampuls.

The present invention relates finally to a new industrial product which comprises an apparatus for making a groove on the peripheral part of a tubular body, particularly on the periphery of a cylindrical glass ampul, characterized essentially in that it comprises in combination means that allow the turning of the tubular body on its own axis at a low rate of speed without moving in the direction of its axis, and means whereby the periphery of a rotating driven abrasive disk is brought into contact with the tubular body, which remains in the same plane.

In a preferred embodiment of the invention, the abrasive disk is mounted on an oscillating member on which there is likewise mounted a lever with a roller, near the part of the abrasive disk that is to work on the tubular body, the said lever being recalled by elastic means that separate its roller from the axis of the said abrasive device and cooperating with a stop that limits its movement toward the axis of the abrasive disk when the oscillating member is moved in the direction of the tubular body.

Other features and characteristics of the invention will appear in the following description, with reference to embodiments shown in the attached drawing in which:

FIG. 1 is a view of the ampuls of the invention stored according to a special embodiment, in perspective;

FIG. 2 is a view in perspective showing how the ampul can be opened by use of the two parts of the cover of the box shown in FIG. 1;

FIG. 3 is a view in section along III--III of the central part of the ampul of FIG. 2;

FIG. 4 is a view in section of a half of the cover of the box along line IVIV of FIG. 1;

FIG. 5 is a view in perspective of an embodiment of the apparatus which effects production of the peripheral groove on the ampuls,

FIG. 6 is a view in section along VIVI of FIG. 5, showing the mounting of the diamond-coated bronze abrasive disk;

FIGS. 7, 8 and 9 show schematically the operation of the feed device for the ampuls;

FIGS. 10, 1 I and 12 show schematically the different stages of production of the peripheral groove on an ampul, and

FIG. 13 is a view in section of the drive rollers along XIII XII] of FIG. 10.

In FIG. 1, there is shown in perspective a plurality of ampuls of the invention (designated as a whole by reference numeral 1) stored in a box 2 whose cover comprises two parts 3 and 4 which can be fixed onto the body of box 2 by sliding along grooves 5 or by perpendicular engagement with the said grooves by virtue of the elasticity of body 2 and parts 3 and 4 of the cover which are made of a semihard plastic material.

As shown in the drawing, parts 3 and 4 which are identical present an orifice 6 at one of their ends, which orifice extends in the present case over above half their length and which, in the embodiment illustrated, presents three ribs 7 which delimit a space that corresponds substantially to the dimensions of ampul 1.

In the illustrated embodiment, body 2 of the box presents in its lower part partitions-8 which allow separation of the different ampuls stored in the box. In the present case, the box is intended to contain six ampuls, but it is obvious that the number can be arbitrary.

As shown in the drawing, ampul l is constituted by a cylindrical tubular body whose two ends 9 are closed in a known rounded form. Ampul 1 contains a plug 10 of lyophilized product that can be of any kind, e.g., live enzymes.

The drawing shows groove 11 on the periphery of ampul 1 near the center thereof. Said groove 11 is constituted by a light out made to a certain depth of the ampul wall, to constitute a weakened zone.

The drawing likewise shows how a self-adhering label 12 is placed above groove 11 all around the ampul.

This label is preferably provided with a self-sticking substance. When the ampul is broken along groove 11 it allows retention of any glass splinters that might break off.

To open the ampul, parts 3 and 4 of the cover of box 2 that are held in each hand are placed on the two ends of the ampul, and using parts 3 and 4 a couple (represented in the FIG. 2 by arrows) is exerted on the ampul, which results in a clean break at the level of groove 11.

It is then only necessary to tilt the part of the ampul that contains the plug of lyophilized product to cause it to fall out of the ampul.

Of course, the ampul can be opened without use of the box cover, simply by taking the ends of the ampul in either hand.

In the embodiment shown, pieces 3 and 4 present ribs 7 which delimit orifices 6. These ribs offer the advantage of holding an ampul with a certain elasticity, but it is clear that they are not indispensable to the invention.

In FIGS. 6 to 13, an apparatus for making groove 11 on ampul l is shown.

It is seen in FIG. 5 that the apparatus comprises two fixed racks whose V notches are intended to receive the ampuls, which are held in position because their ends are guided by fixed plates 21 on both sides of racks 20.

Between the two fixed racks 20 there is a movable rack 22 which effects a step by step drive of the ampuls, moving them from one notch to another.

Movable rack 22 is driven in a circular movement by an arrangement whereby it is articulated at one end, at 23, to a pin 24 which turns about a fixed pin 25. At the other end, the movable rack is articulated at 26 to a plate 27 which is driven in rotation by a motor 28, via a reducing gear 29.

Two rollers 30 and 31 are mounted on either side of the fixed racks at the level of a single notch, and they are driven in rotation in the same direction by a motor 32, by a system of belts and pulleys that is schematically shown in FIG. 5.

At the upper part, an oscillating member 33 is pivoted at 34 on the frame of the apparatus. The oscillating member supports an abrasive disk 35 made of diamond coated bronze, mounted between two plates 36 as shown in FIG. 6. Abrasive disk 35 is driven in rotation by a motor 37 by means of a system of belts and pulleys that is schematically illustrated.

A swinging lever 38, pivoted also on 34, bears at one of its ends a free wheel 39 so placed as to be directly above ampul I which is on rollers 30 and 31.

A recall spring 40 (one of whose ends is rigidly connected to lever 38 while its other end is fixed on oscillating member 33) constantly urges wheel 39 in the direction of ampul 1, until end 41 of lever 38 is applied against an adjustable stop screw 42. Another adjustable stop screw 43 allows limitation of the movement of lever 38 in the other direction, with reference to the oscillating member. Moreover, a recall spring 44 acts on oscillating member 33 to apply abrasive disk 35 against the tube.

A motor 45 which drives a disk 46 by means of a reducing gear 47 causes the oscillation of member 33 by means of a link 48 that is joined by an elongated slot 49 to a stud 50 that is fixed to the end of member 33.

The movement of link 48 and the size of its slot 49 are such that at each turn of plate 46 the link acts during a certain interval to lift the abrasive disk away from ampul 1, whereas during the rest of the cycle link 48 has no efi'ect on the action of the oscillating member because of slot 49.

The speed of motor 32 is set in such a manner that rollers 30 and 31, each provided on its periphery with a rubberized ring 51, are driven with a relatively low peripheral-speed, which may be, e.g., 25 meters per minute. During the operation of the apparatus, motor 32 continuously drives rollers 30 and 31.

Motors 29 and 47 function intermittently to effect the lifting of abrasive disk 35 above ampul l and to synchronize the advance of all tubes that are placed on the racks.

During operation, the motor 39 also permanently drives the abrasive disk at a relatively high peripheral speed, e.g., a rate of 900 meters per minute.

In FIGS. 7 to 9 there is schematically shown the functioning of the step by step advancing device for the ampuls.

In these figures there are again schematically shown a fixed rack 20 and a movable rack 22 which is driven in a movement of rotation about shaft 25.

The successive notches of fixed rack 20 are designated A, B, C, D, and the corresponding notches of rack 22 are designated A, B, C, D.

In FIG. 1, notches A, B, C, D of fixed rack 20 are opposite corresponding notches A, B, C', D of movable rack 22, while the three ampuls I, II, III are placed respectively in notches B, B, C, C, and D, D of the racks.

When movable rack 22 is driven in a movement of rotation, it begins to lift, moving toward the left, and after a quarter turn of plate 27, rack 22 has assumed the position shown in FIG. 8 in which ampuls I, II and III are lifted and moved by a distance equal to half the space that separates two notches.

It is to be noted that by turning plate 27 another quarter turn, movable rack 22 moves to the level of fixed rack 20, with correspondence of the notches, except that it is now notches B, C, D of the movable rack that correspond to notches A, B, C of the fixed rack, each of the ampuls I, II, I" having progressed by one notch toward the left.

When plate 27 effects still another half turn, movable rack 22 moves downward, so that it has no effect on the ampuls.

Thus it is seen that the device effects a step-by-step advance of the ampuls by causing them to pass from one notch to the next.

Now it will be explained how the groove of the invention is made.

In FIGS. 10, ll, 12 there are shown abrasive disk 35, rollers 30 and 31 which support ampul 1, driving it in rotation, the end of lever 38 with wheel 39, and adjustable stop 43.

To explain the operation of the apparatus, it is assumed that a new ampul 1 has just been carried onto rollers 30 and 31 as explained above, while link 48 acts on stud 50 to lift the abrasive disk 35.

From this moment, operation of the device is as follows.

The rotation of plate 46 gradually releases oscillating member 33 which, because of spring 44, swings about shaft 34 in the direction of ampul 1.

Since spring 40 tends permanently to urge wheel 39 toward ampul 1, it is the said wheel 39 that first comes into contact with the ampul 1, being driven in rotation thereby.

However, since spring 44 has sufficient force, abrasive disk 35 continues to descend toward ampul 1, while wheel 39 remains applied thereto and lever 38 pivots with reference to oscillating member 33. This stage corresponds to the stage shown in FIG. 10, the abrasive disk not yet being in contact with the ampul.

Then the abrasive disk which continues to descend comes into contact with ampul I and beings to hollow out groove 11, as shown in FIG. 11.

This work continues until the stop 43 which is rigidly connected to oscillating member 33 is applied against lever 38. In this position which corresponds to that shown in FIG. 12, wheel 39 which bears on ampul l prevents abrasive disk 35 from deepening groove 11. The position of abrasive disk 35 thus remains as indicated in FIG. 12 until plate 46 causes a movement of the link which is sufiicient once more to lift the abrasive disk, which ends the cycle.

It is clear that it is possible readily to adjust the depth of groove 11 by acting on movable stop 43.

it is understood that different embodiments of the invention which have been described above are in no way limiting and that they can be modified in any way that is desirable without exceeding the scope of the invention.

Especially it is clear that the groove made on the periphery of the middle part of the ampul can be made in a manner other than that which has been described. Similarly, the zone of weakening, at the level of which the breaking of the ampul is effected, can be made by a means other than a groove without exceeding the scope of the invention.

Finally, it is clear that although the invention has been described with special reference to ampuls that are to receive lyophilized plug-formed products, the invention applies also to ampuls that contain any kind of products, solid, pulverous or liquid.

What is claimed is:

1. Package for an ampul intended particularly for plugformed lyophilized products, characterized in that it is constituted by a cylindrical glass receptacle closed at its ends, the

said receptacle presenting, toward its middle part, a weakened zone constituted by a groove made on the periphery of the ampul, said package having the form of a box containing a plurality of ampuls and formed of at least two assemblable elements, two of the said elements each presenting an orifice inside of which it is possible to engage an end of the ampul over a certain part of its length to allow the breaking of an ampul by grasping one element in each hand.

2. Package as in claim 1, characterized in that the two elements which each present an orifice form, by their joining on the body of the box, the cover of the said box, each of the two said orifices being disposed inside the cover that is thus formed.

3. Package as in claim 1, characterized in that the two elements are made of a relatively flexible material such as plastic or wood.

4. Package as in claim 1 characterized in that the orifice of each of the elements extends over only a part of the length of these pieces.

5. Package as in claim ll characterized in that the orifice of each of these elements presents at least three ribs on which the ampul bears while it is opened. 

1. Package for an ampul intended particularly for plug-formed lyophilized products, characterized in that it is constituted by a cylindrical glass receptacle closed at its ends, the said receptacle presenting, toward its middle part, a weakened zone constituted by a groove made on the periphery of the ampul, said package having the form of a box containing a plurality of ampuls and formed of at least two assemblable elements, two of the said elements each presenting an orifice inside of which it is possible to engage an end of the ampul over a certain part of its length to allow the breaking of an ampul by grasping one element in each hand.
 2. Package as in claim 1, characterized in that the two elements which each present an orifice form, by their joining on the body of the box, the cover of the said box, each of the two said orifices being disposed inside the cover that is thus formed.
 3. Package as in claim 1, characterized in that the two elements are made of a relatively flexible material such as plastic or wood.
 4. Package as in claim 1 characterized in that the orifice of each of the elements extends over only a part of the length of these pieces.
 5. Package as in claim 1 characterized in that the orifice of each of these elements presents at least three ribs on which the ampul bears while it is opened. 